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Come join our diverse team of experts sharing mutual passion and dedication to addressing unmet needs in progressive multiple sclerosis and ALS.
We are running clinical trials across several indications, domestic and internationally. We are seeking a talented and passionate individual that would thrive in a dynamic, fast- paced, team-oriented environment. The Clinical Trial Director will work closely with the Medical Director, Regulatory, and Scientists. The Clinical Trial Director will independently oversee clinical studies from concept to final close and must be a proactive problem-solver with the ability to critically evaluate and manage budget, timelines and key deliverables. Set up of trial sites, local submissions, database oversight, site communications – “making sure the right things are being done and that things are done right.”
NeuroGenesis (www.neurogenesis-cell.com) is a cell therapy company focusing on developing a unique subpopulation of bone marrow cells that are selected and enhanced to become remyelinating bio-factory cells (NG-01). The platform technology is optimized for treating central nervous system diseases such as multiple sclerosis (MS) and amyotrophic lateral sclerosis (ALS). The NG-01 technology entails collecting of bone marrow from the patient, then by using a proprietary process, identify and enhance a unique subpopulation of bone marrow cells with outstanding nerve therapeutic properties. NG-01 cells are expanded to tens of millions and injected directly into the spinal cord fluid, home-in on the damaged area, take up residence for up to three months and produce sustained, massive amounts of remyelinating proteins to in-situ remyelinate and repair. NeuroGenesis’ initial focus is on progressive MS. To date, more than 140 patients have been treated with NG-01 via an open label study (Published in Jama Neurology), long term studies (4 years, Frontiers of Neurology), a placebo-controlled trial (Brain, Editor’s Choice) as well as compassionate treatments. Neurogenesis is looking for a cell therapy leader with GMP manufacturing expertise to serve as Director of Manufacturing. This is an exciting opportunity to join Neurogenesis and be part of building the company’s cell therapy manufacturing strategy. The ideal candidate will have expertise in cell therapy manufacturing with a demonstrated track record of successful development-to-clinical product transitions.
Job Responsibilities:
Assess internal and external scientific data to better adapt trial designs and interpret trial results
Candidate Requirements:
Key Responsibilities:
The primary accountability of this role is to enable the manufacturing of cell therapy
products for clinical supply, as a cell therapy technical expert for cGMP manufacturing, through providing hands-on technical leadership and operational oversight for a cell therapy manufacturing facility in Rochester, NY.
We are looking for a candidate with excellent GMP, scientific, technical communication, and leadership skills.
Specifically:
Basic Qualifications:
Preferred Qualifications:
Dorit brings expertise and leadership in quality assurance (QA), quality management systems (QMS), CMC, aseptic and cGMP manufacturing, facility design and management, and cross-continent technology transfer of cell therapies (under EU and FDA guidelines). At NeuroGenesis, she oversees all aspects of quality management and regulatory compliance across the organization related to internal/external technology transfers, establishes QMS per the FDA and EU regulations, and prepares the product for advanced clinical phases.
Dr. Snyder has worked on the executive management teams of international pharmaceutical and biotechnology companies in the US and in Israel. For the past 10 years, David was the VP, Clinical Development, Regulatory Affairs at Gamida Cell (NASDAQ: GMDA), a phase 3 cell therapy company. David is highly experienced in the design and management of clinical strategies and protocols as well as the supervision of sponsor interactions with the regulatory agencies in these areas. His focus for nearly the last fifteen years has been advising and directing high-level communications with opinion leaders, consultants and regulatory agencies in the field of cellular therapies. David earned a Ph.D. in medical biochemistry from the Hebrew University.
Dr. Netzer served for over 15 years in cell therapy companies in Israel and in the US as a member of the management team. He is an expert in Stem Cell R&D and operations and in establishing a global strategy for product development, manufacturing, and supply chain, with a clear focus on market viability. Before joining NeuroGenesis, Dr. Netzer served as the VP CMC and Operations at Cell
Cure Neurosciences, acquired by Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), where he led the development of a novel ‘Thaw- and-Inject’ cell product and the building of Lineage’s state of the art GMP manufacturing facility. Previously, Dr. Netzer was the Research Manager at Pluristem Therapeutics Inc. (NASDAQ: PSTI), where he led the preclinical trials and the finding of the first cell therapy product for treating radiation syndrome following nuclear disasters. Dr. Netzer was a Post-Doctoral fellow in cell biology and viral immunology at the NIAID, NIH and holds a PhD in Biotechnology and immunology from the Technion in Israel.
Dr. Kassis is one of the world’s experts in Regenerative Medicine and stem-cells based technologies, and production of clinical-grade stem cells for treating multiple sclerosis andamyotrophic lateral sclerosis patients. Dr. Kassis has over 20 years of experience in developing innovative cellular therapies from bench to patient bedside. Dr. Kassis serves as a Senior Scientist at the Department of Neurology, Hadassah Medical Center. Dr. Kassis has published over 30 publications in prestigious peer reviewed publications.
Dr. Karussis is considered one the world experts in clinical applications of Stem Cells in Neurological diseases, he is the director of MS Center and department of Neuroimmunology, Cell Therapies at Hadassah Medical Center, Jerusalem (since 2007). Dr. Karussis servers on many editorial boards including the International Multiple Sclerosis, Journal of Neurological Sciences, World Journal of Neurology and others. Dr. Karussis has participated in numerous scientific committees at ECTRIMS, EFNS, ISNI and the European School of Neuroimmunology. Dr. Karussis also serves as the president of the Israeli Neuroimmunology Society (since 2010) and has published over 120 peer-reviewed scientific papers mainly in the field of Stem Cells and Neuroimmunology.
An accomplished senior executive with over 16 years of CEO experience in public and private companies in Tel Aviv, New York and Silicon Valley. Established and directly managed global high growth sales, business development organizations in North America, Europe and Asia (direct Sales, Inside Sales, One Tier, Two-Tiered Distribution, OEM, IP Licensing etc.).
CEO of AppDome, a recognized market leader in mobile integration as a service (security, connectivity, mobility). Recognized by CIO magazine as one of 2015’s Top 10 Mobility CEOs as well as a 2015 Top Mobile Innovator by the Channel Company. President and CEO of INKSURE Technologies, the industry leader in cloud-based mobile product authentication. Winner of the 2011 Prestigious ID People Americas Award, the Oscars of the ID Industry, for his contribution to the high-security authentication market. Proven track record in the software, hardware industry of increasing top and bottom-line results, previously heading SanDisk Enterprise (NASDAQ: SNDK) in North America and M-System (NASDAQ: FLSH) Enterprise business. In 2000, founded and served as CEO of Kavado Inc. (acquired by Protegrity Inc.), a global web security solutions provider.
Tal holds an MBA from Columbia Business School in New York and a BA with honors in Economics, Business Administration from the Hebrew University in Jerusalem.